MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	SA-85
Medical Device Problem Codes	Component Missing (2306); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchor system was used for the endovascular treatment of a patient.It was reported during the index procedure that the cassette was missing three endoanchors.It was also reported that one endoanchor dislodged during the procedure and tracked into the patient's left renal artery.As per the physician the cause of the event was related to patient anatomy.The physician reported that the patient had a very short aortic neck with a large angle.No additional clinical sequalae was reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received; it was confirmed that the dislodged endoanchor is still in the renal artery.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9537587
• Report Number: 9612164-2020-00013
• Device Sequence Number: 19448091
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009606200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR